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Sulfatol SS Cream

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Sulfatol SS™ Cream with Sunscreens

Rx Only

PRODUCT DESCRIPTION

Each gram of Sulfatol SS Cream with Sunscreens contains 100 mg of sodium sulfacetamide and 50 mg of sulfur. Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent sulfur.

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Chemically, sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl], monosodium salt, monohydrate. The structural formula is:

INACTIVE INGREDIENTS

Avobenzone USP, Benzyl Alcohol NF, Cetyl Alcohol NF, Cocoglycerides, Dimethicone 200/100, Edetate Disodium USP, Fragrance, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate NF, Light Mineral Oil NF, Octinoxate USP, Polysorbate 60 NF, Propylene Glycol USP, Purified Water USP, Sodium Thiosulfate USP, Sorbitan Monostearate NF, Stearyl Alcohol NF, Xanthan Gum NF.

Sulfatol SS Cream - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sulfatol SS™ Cream with Sunscreens is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sulfatol SS™ Cream with Sunscreens is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This product should not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep away from mucous membranes. Keep tube tightly closed.

Warnings

Although rare, fatalities have occurred due to severe reactions to sulfonamides, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this medication (see ADVERSE REACTIONS section).

Sulfacetamide sodium contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause erythema (redness) and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C

Animal reproduction studies have not been conducted with sulfacetamide sodium. It is also not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium should be given to a pregnant woman only if clearly needed. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well-controlled studies of sulfacetamide sodium in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

It is not known whether sulfacetamide sodium is excreted in human milk following topical use of sulfacetamide sodium. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Adverse Reactions

Although rare, sulfacetamide sodium may cause local irritation, including stinging and burning. Other adverse events associated with the use of sulfacetamide sodium are as follows: Erythema (redness), itching and edema.

Directions

Cleanse affected areas. Apply a thin film 1 to 3 times daily, or as directed by a physician.

How is Sulfatol SS Cream Supplied

Sulfatol SS™ Cream with Sunscreens (sulfacetamide sodium 10% and sulfur 5%) is supplied in 45 g tubes. NDC 51991-302-45

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss: 2/09

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-302-45

Sulfatol SS™ Cream with Sunscreens
Sulfacetamide Sodium 10% and Sulfur 5%

Rx Only
Net Wt. 45 g

For The Topical Control Of

  • Acne Vulgaris
  • Acne Rosacea
  • Seborrheic Dermatitis
SULFATOL SS 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-302
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 100 mg  in 1 g
Sulfur (Sulfur) Sulfur 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Avobenzone  
Benzyl Alcohol  
Cetyl Alcohol  
Coco-glycerides  
Dimethicone  
Edetate Disodium  
Glyceryl Monostearate  
Polyoxyl 100 Stearate  
Isopropyl Myristate  
Light Mineral Oil  
Octinoxate  
Polysorbate 60  
Propylene Glycol  
Water  
Sodium Thiosulfate  
Sorbitan Monostearate  
Stearyl Alcohol  
Xanthan Gum  
Product Characteristics
Color YELLOW (light-yellow) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-302-45 1 TUBE (TUBE) in 1 BOX
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2009 02/28/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Groupe Parima 252437850 MANUFACTURE
Revised: 05/2010
 
Breckenridge Pharmaceutical, Inc.

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